Prodotti competitors / Area Onco-Ema, Area Oncology
CHMP recommends Enhertu for EU approval in previously treated HER2-positive solid tumors
On May 22, 2026, AstraZeneca and Daiichi Sankyo announced that Enhertu (trastuzumab deruxtecan), a HER2-directed antibody–drug conjugate (ADC), received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended Enhertu for approval in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options.
The positive CHMP opinion was based on clinical data from patients with HER2-positive (IHC 3+) tumors across three Phase II studies: DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. In the DESTINY-PanTumor02 trial, Enhertu demonstrated a confirmed objective response rate (ORR) of 51.4% and a median duration of response (DOR) of 14.2 months in previously treated patients with biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other solid tumors. Clinically meaningful responses were also observed in patients with non-small cell lung cancer and colorectal cancer enrolled in the DESTINY-Lung01 and DESTINY-CRC02 studies, respectively.
With a biomarker-selected eligible pt population, Enhertu utilization in patients with IHC3+ HER2 expression is expected to pose a limited competitive threat to Gilead ADC programs in 2L endometrial cancer (EC) and ovarian cancer (OC).
Following this opinion, the European Commission will review the CHMP recommendation and is expected to issue a final decision on the marketing authorization. If approved, Enhertu would become one of the first agents to receive a tumor-agnostic marketing authorization in the EU based on Phase II data in biomarker-selected patient populations. Enhertu currently holds an EMA conditional marketing authorization for other indications.
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